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Electrical Medical Device Certification

Standards compliance certification for devices in lab and factory automation settings

Electrical medical device next to red medical bag defibrillator

Overview

We offer a full suite of services aimed at helping our customers with electrical medical, laboratory and other healthcare related devices. From:

  • testing, certification and standards based compliance testing/evaluation
  • to early design reviews 
  • to gap analysis 
  • to training
  • to documentation review
  • to custom testing
  • and more

UL is a top National Certification Body (NCB) under the International Electrotechnical Commission for Electrical Equipment (IECEE) CB Scheme category for Measurement, Control and Laboratory equipment (MED), and Medical equipment (MED). Customers can use this CB test report and certificate to receive multiple global certification marks, many of which UL can deliver directly. 

We provide integrated test plans that encompass multiple national requirements, reducing rework for global requirements. Simply put, we can test and evaluate your products in our laboratories to the International Electrotechnical Commission (IEC) and the UL 61010 Standard and you can receive approval to use the UL Nationally Recognized Testing Lab (NRTL) Mark, receive an IECEE CB Test Certificate and even fulfill other local country requirements, such as GS and D marks.

Why UL

Global market acceptance 

  • 125-year business experience
  • Operating in more than 143 countries
  • UL has issued more CB Test Certificates than any other body 
  • UL reports and certifications are recognized and accepted around the world
  • UL Marks appear on more than 22 billion products globally

Comprehensive testing and certification services 

  • UL offers field evaluations, on-site training and can come to you for testing
  • Full compliance testing/evaluation to prescans and other preliminary testing 
  • UL has engineers that work with you throughout the production lifecycle 
  • UL’s engineers average more than 10 years in the industry
  • UL has more than 11 industries business units in the company portfolio

Knowledge of global standards and regulatory requirements

  • Covers many markets, e.g., U.S. Food and Drug Administration, Korean Ministry of Food and Drug Safety, European Union In Vitro Diagnostic, EU Medical Devices Directive
  • UL has helped to set more than 1,600 Standards defining safety, security, quality and sustainability
  • UL engineers work with standards committees, such as Association for the Advancement of Medical Instrumentation, American National Standards Institute and government bodies 

State-of-the-art facilities

  • 159 UL laboratories for testing and certification worldwide
  • Tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles
  • More than 10 accredited UL laboratories around the world
  • Semianechoic sites result in virtual zero ambient for optimal test conditions and repeatable results
  • Automated 61010 testing facilities enabled for efficient compliance testing services to help you meet your speed-to-market needs

Medical EMC - FDA and Radio Frequency Identification Devices 

Related standards

  • IECEE CB Scheme 
  • ANSI/AAMI EC 12 
Get in touch

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